1 Preamble
Intensive care medicine saves lives. New developments in medical technology and pharmacology
have brought about a dimension of medical progress that now offers the chance of survival
when formerly death was considered to be inevitable. However, the possibility and
feasibility to sustain and prolong life is not devoid of controversy and tragic consequences,
in particular when death cannot be averted despite the best efforts of ICU clinicians
or when survival is associated with a substantial and permanent reduction of quality
of life. Thus, in view of a poor prognosis, the question frequently arises whether
continuation of intensive care therapy is still appropriate and meaningful or rather
not. Where do we draw the line within the field of technically feasible measures?
What are the perspectives and attitudes of the different parties involved in the treatment
and affected by it?
The Ethics Section of the “Deutsche Interdisziplinäre Vereinigung für Intensiv- und
Notfallmedizin, DIVI” (German Interdisciplinary Association for Intensive Care and
Emergency Medicine) has prepared this policy statement as an aid to orientation for
medical and nursing staff working in critical care medicine. With this paper, the
Ethics Section wants to contribute to an informed and multi-professional discourse
about the appropriateness of therapies and treatment limitations in intensive care
units (ICU). The position paper shall help to examine expectations and hopes in individual
cases by means of specific criteria. Thus, this paper illustrates the responsibility
of the clinicians involved in the care of the respective patient.
The frequently employed Anglo-American term ‘futility’ will not be used here as it
is inadequately defined and often limited to economic cost–benefit analyses. In the
context of patient care, the question whether diagnostic or therapeutic measures are
appropriate and meaningful should be settled without considering economic aspects.
This position paper provides decision-making aids for such situations. Only treatment
concepts that are considered to be appropriate qualify for implementation. After the
appropriateness of therapy has been clarified in a particular case, the given legal
provisions of cost effectiveness according to current German Social Act (Health Law)
must also be observed. However, the process of determining the appropriateness of
individual measures should not be mixed with the societal processes which define the
larger health economic context. Economic considerations must not influence the process
of determining appropriateness in a given case.
2 General considerations
2.1 Goals of intensive care medicine
In general, patients are admitted to the ICU for curative treatment. Intensive care
medicine provides medical and nursing therapies, medical devices, expertise and high
staffing ratios in order to gain time for recovery of impaired or failing vital organ
functions. The main objective is to ensure that patients—even if they do not recover
completely—can lead a life that is independent from ICU care. Thus, in case of success,
intensive care medicine enables survival and the patient’s return to a life that is
as independent and self-determined as possible [14]. However, time and again a patient
becomes completely—and sometimes irreversibly—dependent on life-sustaining medical
devices. In other cases, intensive care treatment results in survival with major mental
and physical deficits that cause a considerable reduction in the patient’s quality
of life and constitute a great and persistent burden for relatives [3, 8].
2.2 Appropriateness/inappropriateness
When discussing treatment approaches, the question whether or not a treatment is overall
meaningful and appropriate must always be taken into account. This refers to the meaning
and relevance of the therapeutic goal and the diagnostic, therapeutic or nursing measures
derived from this goal. The questions about meaning and relevance cannot be answered
in an objective way, but must take into consideration individual and subjective attitudes
of the patients for instance about the meaning of life, death and suffering and assessments
of quality of life, way of living and lifetime goals. These considerations take place
both intuitively, based on “gut feeling” and by a reflective, rational process.
Activities or conditions are considered to be appropriate and meaningful if they are
in some way relevant to achieve one’s (life) goals. What is regarded as a worthwhile
life sustaining treatment by one person might be considered as a meaningless torture
and mere prolongation of the dying process by another. Thus, the assessment of appropriateness
in the sense of being meaningful permits different results for the same treatment
measures. Depending on the point of view, the same measure may be rated as either
“appropriate” or “inappropriate”. Between these two extremes, a continuum of assessments
unfolds in the sense that something can be rated as more or less appropriate. The
question about appropriateness includes two components: instrumental rationality and
value rationality. Both can be considered and discussed separately.
Instrumental rationality describes the adequacy of a measure to attain a certain purpose/goal
(example: “It is appropriate to treat this infection with antibiotics.”). In this
sense, medical or nursing measures are appropriate/meaningful if sufficient experience
or evidence exists to expect that the measure will bring about a success of treatment
with a given probability.
By contrast, a measure is value rational if it expresses or asserts ethical values
(example: “It is appropriate to help a patient who suffers from an infection.”). These
fundamental values are culture- and time-dependent, and deeply rooted in the individual
conceptions of mankind and moral attitudes. Therefore, several issues need to be clarified
when assessing the appropriateness of a treatment, including questions about the value
of the treatment goal, about the meaning of suffering and illness, about subjective
assessments of quality of life, and about the significance of professional and family
support.
Assessing the overall appropriateness of a measure always includes both components
mentioned above. For this reason, the statement that a treatment option is appropriate/meaningful
contains an assessment of its instrumental rationality (it is appropriate from a technical/scientific
point of view) as well as of its value rationality (it is appropriate from a humane
point of view). Attribution of appropriateness may vary depending on the perspective.
Therefore, it must be assessed on a case-by-case basis how physicians, nursing staff,
patients and relatives arrive at their evaluation of appropriateness/meaningfulness,
and which consequences for treatment decisions arise from this assessment.
If the physician (after examination of the criteria listed in point 3.1) determines
that a treatment option is appropriate, this option can be offered to the patient.
Now it is up to the patient to assess the appropriateness of this option from his
point of view (see 3.2). In case the physician does not recognize any degree of appropriateness
for a certain therapeutic measure (after examination of the criteria in point 3.1),
the treatment is not indicated and must not be offered. This medical judgment protects
patients from inappropriate and pointless treatments.
3 Criteria of inappropriateness
When weighing the pros and cons of a measure, issues for consideration are not only
objective facts but also intuitive and emotional valuations that are based on a number
of different perceptions and attitudes. This applies to the professional point of
view (see 3.1) as well as to the patient’s perspective (see 3.2), and these two sides
may come to different conclusions regarding the appropriateness of a measure. A reflective
understanding of criteria for appropriate treatment is a necessary requirement for
qualified and sound decision making.
In many treatment situations it is difficult to justify or provide positive evidence
for the appropriateness and meaningfulness of treatment concepts and measures. The
inappropriateness of a certain treatment approach, however, is much easier to discern.
For this reason, these recommendations list criteria for assessing potential inappropriateness.
To assess whether a treatment concept or measure is inappropriate, the following questions
need to be addressed:
Can the intended goal of therapy be achieved from a medical point of view?
Does the goal of therapy meet the patient’s wishes?
Does the achievable quality of life justify the burdens that arise from the treatment
from the patient’s point of view?
Treatment concepts or measures are inappropriate if
the intended goal of therapy cannot be achieved,
the intended goal of therapy is not supported by the patient’s wishes,
from the patient’s view, the burden that arises from the treatment does not justify
the achievable quality of life.
3.1 Professional perspective
3.1.1 Goals of therapy
A goal of therapy is the intended result of a treatment. It is quite possible that
different members of the team prefer different therapy goals. The following outcomes
can be considered as goal of therapy:
cure,
prolongation of life,
improving quality of life,
symptom control,
end of life care.
These different therapy goals cannot always be distinguished clearly.
Various factors influence the evaluation of therapy goals, including medical facts
and reliable prognostic assessments, individual hopes and experiences, and also professional
ambitions and medico-legal aspects. In case a therapy goal can de facto not be achieved
according to best medical judgment, treatment measures that aim at this goal are inappropriate.
If a therapy goal has a very low probability of success according to professional
judgment, treatment measures intended to reach this goal are not a priori inappropriate
but their indication should be seen as questionable and doubtful [9, 13]. In such
situations, the physician must resolve the question of appropriateness from the patient’s
point of view critically and in-depth with all persons involved.
In case a treatment measure is considered inappropriate, a change of therapy goal
is unavoidable.
3.1.2 Prognosis
A prognosis comprises the assessment of the likelihood of possible disease courses.
This assessment is performed by the treating team and refers to clinical endpoints
like survival, restoration of certain organ functions, quality of life or ability
to communicate. A prognosis is based on relevant clinical findings, statistical probabilities
and physician or nurse expertise; it does not represent a liable prediction of a patient’s
individual course. Prognoses help to estimate whether therapy goals can be achieved
and can thus serve as a measure for assessing their appropriateness.
Irreversibility of a medical condition is a major issue when providing a prognosis.
Irreversibility is not so much a fact that can be ascertained in an objective way
but rather a professional estimate that also includes subjective and individual assessments.
Therefore, declaring irreversibility requires a broad consent within the multi-professional
treating team. An exact prediction of a patient’s fate is impossible; therefore the
tolerable remaining uncertainty needs to be determined in a consensus process (e. g.
“With a probability approaching certainty, this condition is irreversible.”). By coming
to a consensus about the irreversibility of a condition, the treating team takes over
responsibility for the remaining minimal and acceptable probability of error.
Use of scoring systems for prognosis is only appropriate in the context of clinical
studies where scores serve to describe patient cohorts, for quality improvement measures
and for predictions based on large populations of intensive care patients. An individual
prediction of a patient’s prognosis is not possible due to the remaining significant
uncertainty.
3.1.3 Patient wishes/autonomy
Interventions which are medically considered appropriate may only be carried out if
they are in line with the patient’s stated or presumed wishes. For this reason, the
patient’s wishes must be elicited by all means. On the other hand, decisions must
not be driven by the treating team’s own values. If patients are mentally incapacitated,
it is up to their legal proxy to find out and assert the patient’s preferences and
wishes [9].
3.1.4 Quality of life and burden
Present and future quality of life is intuitively assessed by the members of the treating
team. However, this assessment must not serve as a basis for deciding whether further
treatment is appropriate or not. This decision is reserved for the patient. In order
to make sure that the patient can competently weigh his options, the information about
possible disease courses and foreseeable impairment of the quality of life must be
honest and comprehensible. Desired as well as undesirable treatment effects have to
be discussed, including consequences which affect the patient as well as the relatives
(e. g. survival without regaining consciousness).
3.2 Patient perspective
3.2.1 Therapy goal
Assessing whether or not a therapy goal can be achieved is the task of the physician
in charge. But it is up to the patient to decide if therapy goals which are achievable
are also desirable and if they are to be pursued. This decision is influenced by the
patient’s values, philosophical and religious beliefs, way of life and plans for the
future, hopes and fears. In order to make a sound judgment about therapy goals that
are in principle achievable, the patient or his legal representative have to be informed
in detail by the physician about the medical condition which can be expected after
the therapy goal is achieved.
3.2.2 Prognosis
The patient or his legal proxy is informed about the prognosis. This means that they
are informed about the individual probability of actually achieving those therapy
goals (listed in 3.1.1) which are in principle achievable. In this context, it is
necessary to point out the general uncertainty of prognosis. However, the evaluation
of the prognosis is up to the patient. Consequently, the patient must decide whether
or not a certain prognosis is acceptable from his point of view. The patient will
agree to a further treatment only if he deems the prognosis acceptable and worthwhile.
From the patient’s perspective, the decision does not rest on the probability of success
alone. It seems reasonable to consider a prognosis as good if the probability of success
is high. In return, a low probability of success can justify a negative assessment.
But even if the probability of success is low, many patients see reason for hope.
From the patient’s point of view, whether hope exists or not does not depend on the
factual probability alone, but also on the theoretical possibility of a positive outcome.
The difference between optimism and hope should therefore be taken into account when
deliberating with the patient or his legal representative.
3.2.3 Patient wishes/autonomy
The patient’s right of self-determination is a valuable ethical achievement that is
protected by law. The patient’s wishes have to be respected [5]. Concerning potentially
inappropriate treatment this means: autonomy can only become effective if it is supported
and empowered. This includes patient-oriented, open and unbiased patient information
and the willingness to explain therapy goals and prognoses within a patient–doctor
relationship based on mutual trust.
The patient’s wishes are not always unambiguous and may change in the course of treatment.
Especially in case of competing or contradictory interests, repeated counseling and
support from the treating team is necessary. There may be considerable ambivalence
about the appropriateness of further treatment. In the process of consultation, the
patient’s moral values and his presumed perspective on the progression of his disease
should be addressed.
In case of inconsistencies in the patient’s wishes—e. g. between the patient’s advance
directive and his consent to a recently performed operation, or if a patient who is
not fully competent makes verbal statements that are discrepant to previously stated
wishes—this inconsistency has to be clarified as far as possible: Do these current
declarations of will constitute a revocation of the patient’s advance directive? Up
to which extent do preoperative discussion and the patient’s consent to an operation
justify subsequent life support and at which point in time is a new assessment and
a new decision required that are in line with the previously stated patient wishes?
3.2.4 Quality of life/burden
The WHO defines quality of life as “an individual’s perception of their position in
life in the context of the culture and value systems in which they live, and in relation
to their goals, expectations, standards and concerns” [15] (English definition available
at www.who.int/mental_health/media/68.pdf). Accordingly, quality of life is an individual
assessment that might change over time and that is difficult to ascertain in an objective
way. However, the question: “How does the patient assess his current and his expected
quality of life and does he accept the latter?” must not be ignored. This question
cannot be answered but by the patient himself, and the answer only applies to the
current situation. Assessment of the possible future quality of life is limited by
the fact that this assessment can change when the future situation is actually experienced.
For example, needing a wheelchair might be deemed unacceptable by a healthy person
whereas the same person might come to an entirely different assessment when actually
experiencing this situation.
Additional factors which play a role for the patient’s assessment are the physical
and emotional burdens of intensive care therapy. For the patient, therapeutic measures
can be painful and invasive and often involve a loss of control, privacy and personal
rights. Acceptance of these impairments is higher when therapeutic measures are considered
appropriate and meaningful. With declining degree of appropriateness, growing emphasis
is placed on potential burdens and impairments when re-assessing therapy goals.
3.3 Treatment attempt
In case it is not possible to make a prognosis with sufficient certainty, a limited
treatment attempt can help to come to a definite decision. In this case, a potentially
appropriate treatment is started in order to see if it is successful. Even if the
treatment is not successful or of doubtful success, the attempt helps all persons
involved to come to a definite decision. Such a treatment attempt for the purpose
of guiding future decision making must aim for a clearly defined therapy goal that
is reasonably achievable. In addition, the therapy goal should be achievable within
a limited period of time (e. g. “If cardiac function does not improve within one week,
…”). Otherwise, there is the risk that a definite decision is delayed from one elusive
hope to another.
4 Challenges of implementation
4.1 Decision-making under uncertainty
Medical prognoses provide an uncertain forecast for the individual course of disease.
There always remains a certain degree of uncertainty the treating team needs to be
aware of. Especially in intensive care medicine, a patient’s condition can change
dramatically and unexpectedly. For this reason, prognoses as well as resulting decisions
need to be scrutinized and readjusted regularly.
This uncertainty must not be ignored when talking to patients and relatives. It is
necessary to explain all different possible courses the disease can take and to openly
discuss resulting consequences. However, this is contrary to the need for unambiguousness
of some patients and relatives. Medical professionals should avoid pretending such
unambiguousness.
4.2 When successful treatment seems unlikely
In certain situations, the chances of a positive treatment outcome seem quite unlikely.
The indication for life sustaining treatment cannot automatically be denied in these
situations, but it remains doubtful and questionable.
First, therefore, the multi-professional treating team should reach a consensus. Subsequently,
physician and ICU team must consider carefully together with the patient and/or his
legal proxy by weighing up medically feasible treatment options against what is considered
appropriate from the patient’s point of view, in order to define individual limitations
of therapy [7, 9, 11].
This requires regular and open discussions between patient (and/or legal proxy), relatives
and treating team [2]. Such a dialog permits all parties involved to come to a conclusion
about the appropriateness of a specific therapy when the chances of success are very
limited and the risk of medical complications or treatment burden is high.
When the probability of achieving a given therapy goal is unpredictable, but if there
is no time for joint decision making due to high urgency, a treatment attempt appears
justified. However, it is strongly recommended to re-evaluate the decision after a previously
agreed interval.
4.3 When survival appears almost impossible
In case the patient’s survival appears impossible with a justifiable remaining uncertainty,
the therapy goal must be changed towards palliation [12]. This decision should be
disclosed to the patient and his relatives or to the legal proxy in an empathic and
open manner in order to obtain their understanding and agreement if possible.
However, consent of the patient or his proxy is not legally required in such situations.
If medical treatment is (or has become) inappropriate or impossible, there is—according
to German jurisdiction—a priori no scope for the right of self-determination. A prerequisite
for the dialog between the physician and the proxy is the presence of a given indication
for therapy. The physician bears sole responsibility for the indication.
However, in individual cases, there might be reason for continuing inappropriate life
sustaining treatments for a limited period of time. This includes the maintenance
of organ function for planned organ donation [6] or bridging time so that relatives
can bid farewell to the dying patient, as long as this does not contradict his or
her will.
An unjustified wait-and-see attitude, i. e. avoiding or denying the decision to modify
the therapy goal, is also a kind of decision. As this attitude can cause the patient
considerably more suffering than benefit in the final phase of life, it is not acceptable
[9].
4.4 When the therapy goal is inappropriate from the patient’s point of view
Sometimes the patient does not agree to therapy goals that are achievable from a medical
point of view because they are not in line with his idea of a life worth living. It
might also be possible that a patient rejects a therapy goal because he does not accept
the treatment burden. In both cases, treatment is inappropriate and meaningless from
the patient’s point of view and must not be provided.
The treating team has to realize that regardless of medical results and criteria,
the patient might question the appropriateness of medically indicated therapies because
of his individual assessments. Amongst others, these include ideas of a successful
life, dying with dignity, significance of death, individual life goals and aspects
of quality of life. In any case, before life sustaining treatment is withdrawn on
request of the patient, it has to be ensured that the patient’s assessment of the
situation is not based on a temporary mood or caused by his illness. In case of doubt,
an independent professional assessment (for instance by a psychiatrist) should be
carried out.
If the patient considers that further treatment is meaningless and inappropriate,
ignoring the patient’s will cannot be justified by the claim that the physician is
fulfilling a presumed obligation to help, at least according to German legal stipulations.
Rather, further treatment would constitute an offence of criminal assault.
4.5 Procedure in cases of conflict
Differences in opinion may arise among the persons involved about whether therapy
goals are achievable or whether treatment options are appropriate; these differences
can delay or even foil necessary decision making. Within the treating team, varying
professional judgment can lead to conflicts on different levels of hierarchy as well
as among medical specialties and health care professions. Health care providers should
always check in a self-critical way if irrelevant motives or competing interests might
influence their assessment [16]. Conflicts can also arise among relatives or between
relatives and the treating team.
Personal involvement, emotional distress and the perception of being at the mercy
of the treating team might make it difficult for patients and relatives to focus on
relevant issues and to formulate and ask relevant questions. However, the appropriateness
of therapy goals and measures can only be adequately assessed if all stakeholders
are involved. It is the treating team’s task to provide an adequate atmosphere for
this assessment, regardless of their heavy workload. Likewise, each member of the
treating team—whatever their professional group or level of hierarchy—must be allowed
to ask questions about the appropriateness of intensive care measures and to voice
their concerns about possible influence of external forces and motives on therapy
decisions.
Over all, good interdisciplinary and interprofessional communication is critical and
should also be practiced by the team leaders in order to avoid and resolve conflicts.
Good communication includes regular team meetings, if necessary together with colleagues
from other departments, and structured discussions with relatives [7]. External assistance
can be requested in form of an ethics case consultation by clinical ethics committees
[4], or palliative care consultation [10].
Uncertainty about the implications of legal regulations concerning end-of-life decisions
[1] can have the effect that a written or orally expressed patient wish, and thus
the patient’s autonomous will, is disregarded. Regular pre- and postgraduate education
on ethical, legal and palliative care issues, accompanied by continuous self-reflection,
can help to provide clarity.
In cases of conflict within the family about meaningfulness and appropriateness of
life-sustaining measures, the ICU team is usually not—or only to a very limited extent—able
to help resolve these conflicts. However, even if a consensus cannot be reached, the
assessment of appropriateness in terms of instrumental rationality remains the task
and responsibility of physicians.
5 Decisional support
Evaluating the appropriateness and meaningfulness of therapy goals and treatment measures
requires an assessment by all persons concerned. Whether the probability of success
is sufficiently high, or whether the patient’s expressed wishes have been sufficiently
ascertained, has to be resolved individually and cannot always be confirmed objectively.
The following questions can be used as an aid to contribute towards these assessments.
5.1 Questions to be considered among the treating team
Do you think it is likely that the patient will survive the current situation?
Is the prognosis of survival based on objective assessment methods?
Do you believe that in case of survival, the patient will regain a health condition
that meets his ideas of an acceptable quality of life?
Does an advance directive exist that clarifies the patient’s position?
Do you have any other information about the patient’s expressed or presumed wishes?
Do you assume that the current measures of therapy are appropriate from the point
of view of the patient to improve his health condition and his quality of life?
Do you think it is possible that the current diagnostic and therapeutic measures are
an unacceptable burden for the patient and will further deteriorate the patient’s
quality of life?
Do you expect an improvement of the current situation (in terms of improvement of
the quality of life during the current therapy)?
Which short-term therapy goals would indicate an improvement?
Do you perceive any circumstances (hopes and expectations within the team, of individual
team members, of relatives) that make it difficult to assess the appropriateness or
inappropriateness of therapy?
Have such circumstances already been discussed between all persons concerned?
Do all persons concerned share the treating physician’s assessment of appropriateness
or inappropriateness?
5.2 Questions supporting self-reflection of proxies or relatives
What are your own wishes? What are your wishes for the patient? What do you presume
the patient wishes himself?
Are you aware of the fact that it is highly unlikely that the patient survives this
stage of disease?
Are you aware of the reduction in quality of life in case the patient survives this
stage of disease (for instance dependency on care, inability to communicate)?
Of what significance are these considerations for your assessment?
Did you check if the current medical situation and the current therapy goal are in
line with the patient’s advance directive or with the preferences the patient expressed
in the past?
What other statements of the patient in the past (apart from the patient’s advance
directive) could be relevant to find out what the patient might want in the current
situation?
Examples: How did he handle diseases? What were his experiences with death and dying
of others? What was important to him in life? What was his conception of quality of
life? What life plans did he have at last?
Do you feel sufficiently informed for assessing the appropriateness and meaningfulness
from the patient’s point of view?
It is strongly advised to document the results from these reflections in a structured
way so that all relevant considerations and assessments are available for all persons
concerned.